Monday, January 14, 2008

January 15, 2008 - Drug Warning from new study released - This new study is brought to you as a service from Dr Steven Horvitz and The Institute for Medical Wellness.

The long-awaited results of a trial of Zetia, a cholesterol-lowering drug prescribed to about a million Americans, shows the drug confers no medical benefit to users. If you are on this medication and need further information please call our office at 856-231-0590.

Cholesterol Drug Zetia Doesn't Cut Heart Attack Risk: Study

Date updated: January 14, 2008Content provided by Health Day

MONDAY, Jan. 14 (HealthDay News)-- The long-awaited results of a trial of Zetia, a cholesterol-lowering drug prescribed to about a million Americans, shows the drug confers no medical benefit to users.

In fact, the pace at which artery-clogging plaques formed within vessels almost doubled in patients taking Zetia (ezetimibe) along with another cholesterol-lowering drug, Zocor (simvastatin), compared to those taking Zocor alone, the study found.

The two medications -- ezetimibe plus simvastatin -- are also marketed in one prescription pill, called Vytorin. About 60 percent of U.S. patients who are taking Zetia now receive the drug as part of Vytorin.

But the new two-year trial of 720 patients sheds doubt on whether it makes any sense for people battling cholesterol to take Vytorin versus Zocor alone, experts said. The study was funded by the two companies that make Zetia, Merck and Schering-Plough.

"This wraps it up," said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic. "That's all there is. There just isn't any evidence that adding ezetimibe to simvastatin produces any advantage."

No one is disputing that Zetia can lower levels of LDL "bad" cholesterol by 15 percent to 20 percent -- that had been shown in previous trials. However, whether that reduction led to any greater lowering of heart attack or stroke risk had remained unclear.

The new ENHANCE trial -- which involved patients with a genetic condition that causes abnormally high levels of blood cholesterol -- found no such added benefit. According to a statement released by the two drug companies Monday, researchers found no statistically significant difference in heart attacks or stroke among trial participants who took Zetia plus Zocor, a widely used cholesterol-lower drug, versus those who got Zocor alone.

The study also noted that the speed at which arteries thickened with plaque almost doubled among those on the two-drug regimen compared to those taking Zocor alone.

Safety profiles were similar for Zetia/Zocor versus Zocor alone, the team added.

"These results are very important considerations on how we treat patients with elevated cholesterol and will very likely impact the way we choose drugs to lower cholesterol and eliminate plaque," said Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardio-Vascular Disease at New York University Medical Center, New York City, and clinical associate professor at the NYU School of Medicine.

"ENHANCE found that plaque got slightly worse when the drug combination was used," Weintraub noted in a statement. "But, the real take-home message here is that getting LDL down is important, and that's not something that should be lost as a consequence of this study."

The ENHANCE study was completed in April 2006, but the results were only released Monday by Merck and Schering-Plough after continual prodding by medical professionals. According to The New York Times, the companies had initially planned to release the findings by March 2007, but then missed several self-imposed deadlines, blaming the delay on the complexities of necessary data analysis.

Now that the results have arrived, Zetia and Vytorin should be viewed as "drugs of last resort," for patients not helped by standard statin therapy, Nissen said. Only if you can't tolerate full doses of simvastatin should you take ezetimibe, he said.

"This is one of the most widely advertised and widely used drugs out there, so it's obviously good to get these study results," Nissen added.

Another group questioned why patients should be prescribed more expensive cholesterol-lowering drugs, such as Vytorin, versus cheaper, generic statins such as Zocor.

"We already know that millions of people who take these brand drugs probably don't need to; they could be taking a less expensive generic instead. This study lends support to that cost-saving strategy for the health system and for consumers," said Steven Findlay, managing editor of Consumer Reports Best Buy Drugs, a public information and education project of Consumers Union, publisher of Consumer Reports.

"If there is no apparent clinical benefit, why take a drug that cost three or four times more?" Findlay said in a statement. "Most people do not need that magnitude of cholesterol reduction anyway."

Sales of Zetia and Vytorin totaled $3.7 billion in the nine months ending Sept. 30, up 33 percent from a year ago. Analysts estimate that about 70 percent of Schering-Plough's earnings depend on the drugs, the Times noted.

I have questioned at times the use of any cholesterol lowering medication. While they do lower cholesterol, how much does the cholesterol lowering actually benefit each individual. Most of the cholesterol lowering studies have shown dramatic decreases in total and bad (LDL) cholesterol, sometimes up to 50% reductions. However the actual percentage of patients who benefit by not having a heart attack, stroke, or cardiac death averages out to about 6%. 6% means that for every 16 people you treat, one person will benefit. While we never know who that one person will be, and we all hope that it will be ourselves, what about the other 15 patients who have had no benefit? In my practice I explain all options to my patients about cholesterol, the good, the bad, and the indifferent. Together, we make a decision as to whether medication for cholesterol is an advantage or not.

Dr Jennifer Phillips, Naturopathic Physician and part of the Institute for Medical Wellness network has these thoughts:

“Lately the fear of cholesterol has almost become an obsession. What many people do not realize is that cholesterol is necessary for the body to function. Problems begin when the body has too much cholesterol, but there are many natural therapies to bring down cholesterol levels. The human body manufactures 60 - 75% of its total cholesterol for its own use. The body uses cholesterol as glue to keep cell membranes from falling apart. It also is one of the building blocks for many of the body’s hormones such as estrogen, testosterone and cortisone.

Besides reducing intake of overall dietary fats and SUGARS, another way to lower cholesterol levels is to increase its elimination from the body. Oat bran and apples are especially good absorbing agents, but evidence suggests that increasing fiber of any kind in the diet will decrease cholesterol levels. Half-a-cup serving of cooked pinto or navy beans daily can lower LDL cholesterol levels by 20%.

Coffee, both regular and decaf, has been implicated in high cholesterol levels and reducing its consumption is suggested.

Exercise can dramatically increase the HDL’s and to some extent, decrease the cholesterol-depositing LDL’s. The best kind of regimen would be 30-45 minutes brisk walking, cycling or swimming three to four times a week.

Certain fish and plant oils will reduce cholesterol in some people. Niacin can lower LDL’s and increase HDLs significantly and has been proven to decrease the risk of heart attack. Lecithin has been shown to significantly lower LDL cholesterol while raising HDL. Garlic tablets can also lower cholesterol. Onion and garlic can be used liberally in your cooking as well.

High levels of cholesterol are associated with many life-threatening diseases but there are a number of dietary measures that can lower and/or control levels. If periodic checks are made by a doctor and common-sense dietary changes are made as needed by the patient and kept up over time, atherosclerotic disease can be reduced and the problems it cause prevented and possibly even reversed.”

Saturday, January 12, 2008

January 12, 2008 - Drug Warning from FDA - This FDA warning is brought to you as a service from Dr Steven Horvitz and The Institute for Medical Wellness.

A drug warning has recently been announced by the FDA regarding medications used to fight Osteoporosis. If you are on one of these medications and need further information please call our office at 856-231-0590.

FDA Provides Updated Information on Bisphosphonates

ROCKVILLE, MD -- January 7, 2008 -- FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.

The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

This severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgias, and arthralgias that sometimes accompanies initial administration of intravenous bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.